| Class 2 Device Recall CORFLO 300 Enteral Pump | |
Date Initiated by Firm | September 19, 2011 |
Date Posted | October 25, 2011 |
Recall Status1 |
Terminated 3 on December 27, 2017 |
Recall Number | Z-0089-2012 |
Recall Event ID |
59969 |
510(K)Number | K944750 |
Product Classification |
Pump, infusion, enteral - Product Code LZH
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Product | CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500.
Intended to deliver formula to patients requiring tube feedings. |
Code Information |
catalog 20-0500, all serial numbers |
Recalling Firm/ Manufacturer |
CORPAK MedSystems 100 Chaddick Dr Wheeling IL 60090
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For Additional Information Contact | 800-323-6305 |
Manufacturer Reason for Recall | Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure. |
FDA Determined Cause 2 | Process control |
Action | Corpak MedSystems sent Recall Notification letters dated September 19, 2011 to all CorFlo 300 Enteral Pump customers on the same date. The customers were informed that there is a possibility that with fluid ingress the keypad may become inoperable, and that there is a possibility of motor mount failure. Either event could possibly affect the rate at which formula is delivered to the patient, and fluid ingress could cause a potential of audible alarm failure. Corpak determined that the removal of the pumps from the market was the best option for their customers, and requested the return of all CorFlo 300 pumps to Corpak by no later than December 1, 2011. The customers were requested to contact Corpak at 1-800-323-6305 to arrange for the return of the pumps, and to complete and return the enclosed acknowledgement form, indicating the number of pumps on hand, via fax at 847-541-9526 or e-mail to questions@corpak.com. Dealers/distributors were requested to notify their customers of the recall. |
Quantity in Commerce | 13,000 pumps |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LZH
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